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PMA Final Decisions Rendered for March 1995 |
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A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available. Information about the PDF Reader is available.
P910067/ EXIMED UV200LA SUMMIT TECHNOLOGY, INDICATED FOR USE IN
03/10/95 EXCIMER LASER INC. PHOTOTHERAPEUTIC
SYSTEM SVS APEX WALTHAM, MA KERATECTOMY (PTK)
EXCIMER LASER 02154 SYSTEM PROCEDURES UNDER
CERTAIN CONDITIONS
P920055/ BOSTON ADVANCE POLYMER TECHNOLOCY INDICATED FOR
03/01/95 COMFORT FORMULA DIV WILMINGTON PART L.P. DISINFECTING AND
CONDITIONING WILMINGTON, MA SOAKING FLOURO
SOLUTION 01887 SILICONE ACRYLATE AND
SILICONE ACRYLATE
RIGID GAS PERMEABLE
CONTACT LENSES
P930035 VENTAK P2 AICD CARDIAC PACEMAKERS, INDICATED FOR THE
03/10/95 SYSTEM MODEL INC. TREATMENT OF PATIENTS
1625 VENTAK P2 ST. PAUL, MN WITH VENTRICULAR
PULSE GENERATOR, 55112-5798 FIBRILLATION AND/OR
MODEL 2835 VENTRICULAR
SOFTWARE MODULE, TACHYARRHYTHMIAS WHO
MODEL 2815 VENTAK ARE AT HIGH RISK OF
ECD EXTERNAL SUDDEN CARDIAC DEATH
CARDIOVERTER
DEFIBRILLATOR
N50510 /S061 VITEK SYSTEMS BIOMERIEUX VITEK, INC. REMOVAL OF THE
03/01/95 GENERAL DISCLAIMER FOR
SUSCEPTIBILITY HAZELWOOD, MO PSEUDOMONAS/AZTREONAM
CARD 63042-2395
P810002/S33 ST. JUDE MEDICAL ST.JUDE MEDICAL, INC. USE OF GENERAL
03/14/95 MECHANICAL HEART SUTURING INSTRUCTIONS
VALVE ST. PAUL, MN IN LIEU OF SPECIFIC
55117 SUTURING INSTRUCTIONS
P810025/S15 AMVISC AND AMVISC IOLAB CORPORATION ALTERNATE ANIMAL
03/10/95 PLUS MODEL FOR
CLAREMONT, CA INFLAMMATORY TESTING
91711 OF AMVISC AND AMVISC
PLUS VISCOELASTICS
P810046/S151 SIMPSON-ROBERT ADVANCED CHANGES IN THE
03/23/95 CORONARY BALLOON CARDIOVASCULAR SYSTEMS INSTRUCTIONS FOR USE
DILATATION SANTA CLARA, CA
CATHETER ACS 95052-8167
STACK PERFUSION
CORONARY
DILATATION
CATHETER
P810046/S153 SIMPSON-ROBERT ADVANCED MATERIAL
03/23/95 CORONARY BALLOON CARDIOVASCULAR SYSTEMS MANUFACTURING AND
DICTATION SANTA CLARA, CA LABELING CHANGES TO
CATHETER ACS RX 95052-8167 THE ACS RX PRIMAFLOW
LIFESTREAM CORONARY DILATATION
CORONARY CATHETER
DILATATION
CATHETER
P820021/S026 NEWVUEW, NEWVUES CIBA VISION CORP. ADD THE MONOVISION
03/31/95 SOFTCOLORS, FOCUS FITTING TECHNIQUE TO
VISITINT, FOCUS ATLANTA, GA THE LABELING OF A
SOFTCOLORS 30360 SINGLE VISION CONTACT
HYDROPHILIC LENS TO MANAGE
CONTACT LENSES PRESBYOPIA
P820060/S8 ABBOTT AXSYM AFP ABBOTT LABORATORIES MODIFICATIONS TO THE
03/27/95 ABBOTT AFP EIA DEVICE
ABBOTT PARK, IL TO FACILITATE THE USE
60024-3500 OF THE ASSAY ON THE
ABBOTT AXSYM ANALYZER
NEW TRADE NAME ABBOTT
AXSYM AFP
P830026/S61 MODEL 522-12 INTERMEDICS, INC. APPROVAL FOR THE
03/09/95 RX5000 PROGRAMMER RX5000 MODEL 522-12
ANGELTON, TX PROGRAMMER WITH
77515 ACCESSORIES
P830045/S47 MODEL 3202A SIEMENS PACESETTER, APPROVAL FOR THE
03/27/95 FUNCTION PACK INC. MODEL 3202A FUNCTION
SYLMAR, CA PACK FOR USE WITH THE
91392-9221 APS II MODEL 3003
PROGRAMMER
P830066/S11 ABBOTT AXSYM CEA ABBOTT LABORATORIES MODIFICATIONS TO THE
03/27/95 ABBOTT CEA EIA DEVICE
ABBOTT PARK, IL TO FACILITATE THE USE
60064-3500 OF THE ASSAY ON THE
ABBOTT AXSYM ANALYZER
NEW TRADE NAME AXSYM
CEA
P840068/S22 SSI PACEMAKER CARDIAC PACEMAKERS VIGOR SSI PACEMAKER
03/15/95 SYSTEM WITH INC. SYSTEM WITH MODELS
MODELS 460 AND 465 ST PAUL. MN 460 AND 465 PULSE
PULSE GENERATORS, 55112 GENERATORS AND MODEL
AND MODEL 2055 2055 SOFTWARE MODULE
SOFTWARE MODULE
P850051/S45 MEDTRONIC SINGLE MEDTRONIC INC. USE OF TECOTHANE 75D
03/01/95 CHAMBER POLYURETHANE RESIN,
PACEMAKERS MINNEAPOLIS, MN PRODUCED BY
55432-3576 THERMEDICS, INC.
ALTERNATE MATERIAL
FOR THE PELLETHANE
75D RESIN FOR THE
CONNECTOR MODULE
P860007/S15 INTERTACH II INTERMEDICS, INC. USE OF WILSON
03/01/95 MODELS 262-16 GREATBACH BATTERIES/
ANGLETON, TX MODIFICATION BATTERY
77515 SPECIFICATIONS
P860012/S5 ALVEOFORM COLLAGEN CORPORATION ALTERNATE
03/21/95 BIOGRAFT IMPLANT MANUFACTURING PROCESS
PALO ALTO, CA FOR ALVEOFORM
94303 BIOGRAFT IMPLANT
P880003/S32 TITAN 18 PTCA CORDIS CORPORATION APPROVAL FOR A TEAL
03/09/95 DICTATION OUTER BODY, A RATED
CATHETER MIAMI, FL BURST PRESSURE OF
33102-5700 SIXTEEN (16) ATM, A
MODIFIED ATTACHMENT
OF THE BALLOON
MARKERBAND, LENGTHS
OF 9 AND 18 MM
P880003/S33 CORDIS PTCA CORDIS CORPORATION MODIFICATION OF THE
03/21/95 DILATATION EXIT MARKER MATERIAL
CATHETER TRAKSTAR MIAMI, FL AND APPLICATION
PTCA DILATATION 33102-5700 PROCESS
CATHETERS
P880006/S21 MODEL 3202A SIEMENS PACESETTER, APPROVAL FOR THE
03/27/95 FUNCTION PACK INC. MODEL 3202A FUNCTION
SYLMAR, CA PACK FOR THE USE WITH
91392-9221 THE APS II MODEL 3003
PROGRAMMER
P880027/S31 SCHNEIDER PFIZER HOSPITAL USE OF THE DYMAX 190M
03/24/95 MICROSOFTRAC PTCA PRODUCTS GROUP AS THE HUB-TO-STYLET
CATHETER MINNEAPOLIS, MN RETAINER ADHESIVE AND
SCHNEIDER 55442 AN ADDITIONAL TO THE
FREEHAND AND MC DEVICE LABELING
RAIL 20/30/40
PTCA CATHETERS
P880027/S32 SCHNEIDER PFIZER HOSPITAL ALTERNATE DESIGN OF
03/23/95 MICROSOFTRAC PTCA PRODUCTS GROUP THE OVER-THE-WIRE
CATHETERS MINNEAPOLIS, MN SCHNEIDER MYSTIC PTCA
SCNEIDER 55442 CATHETERS NEW TRADE
FREEFLIGHT PTCA NAMES SCHNEIDER
CATHETERS FREEFLIGHT 20, 30, 40
RCA CATHETERS
P880027/S33 SCNEIDER PFIZER HOSPITAL ALTERNATIVE DESIGN OF
03/24/95 MICROSOFTRAC PTCA PRODUCTS GROUP THE SCNEIDER FREEHAND
CATHETER FREEHAND MINNEAPOLIS, MN PTCA CATHETER, NEW
20/30/40 PTCA 55442 TRADE NAMES FREEHAND
CATHETERS 20, FREEHAND 30, AND
FREEHAND 40 PTCA
CATHETERS
P880086/S29 MODEL 3202A SIEMENS PACESETTER, APPROVAL FOR THE
03/27/95 FUNCTION PACK INC. MODEL 3202A FUNCTION
SYLMAR, CA PACK FOR USE WITH THE
91392-9221 APS II MODEL 3003
PROGRAMMER
P880090/S12 STORZ MOSEL 120 STORZ OPHTHALMICS, INC. LABELING CHANGES FOR
03/31/95 UV AND NON-UV THE MODELS 120 AND
ABSORBING CLEARWATER, FL 120 UV INTRAOCULAR
INTRAOCULAR LENS 34619 LENSES
FAMILY FOR
ANTERIOR OR
POSTERIOR CHAMBER
PLACEMENT
P890003/S32 MEDTRONIC DUAL MEDTRONIC, INC. USE OF TECOTHANE 75D
03/01/95 CHAMBER POLYURETHANE RESIN,
PACEMAKERS MINNEAPOLIS, MN PRODUCED BY
55432-3576 THERMEDICS, INC. AS
AN ALTERNATE MATERIAL
FOR PELLETHANE 75D
RESIN FOR THE
CONNECTOR MODULE
P890057/S5 MODEL 3100A HIGH SENSORMEDICS SEVERAL DESIGN
03/23/95 FREQUENCY CORPORATION CHANGES
OSCILLATORY YORBA LINDA, CA
VENTILATOR 92687
P900023/S14 ABIOMED BVS 5000 ABIOMED, INC. ADDITIONAL SIZE
03/23/95 BI-VENTRICULAR ATRIAL CANNULA,
SUPPORT SYSTEM DANVERS, MA THE 36 FRENCH FLANGED
01923 BENDABLE ATRIAL
CANNULA, TO BE USED
WITH THE BVS 5000
BI-VENTRICULAR
SUPPORT SYSTEM
P900030/S3 CONTIGEN BARD COLLAGEN CORPORATION USE OF BARD
03/03/95 COLLAGEN IMPLANT TRANSURETHRAL
PALO ALTO, CA INJECTION SYSTEM KIT
94303-3308
P900039/S6 COLLAGRAFT BONE COLLAGEN CORPORATION ALTERNATE
03/21/95 GRAFT MATRIX MANUFACTURING PROCESS
PALO ALTO, CA FOR THE COLLAGRAFT
BONE GRAFT MATRIX
P900061/S7 MEDTRONIC MODEL MEDTRONIC, INC. MEDTRONIC MODEL 7219D
03/17/95 7219D JEWEL PCD JEWEL PCD ARRHYTHMIA
ARRHYTHMIA CONTROL MINNEAPOLIS, MN CONTROL SYSTEM
SYSTEM 55432-3576
P910001/S9 SPECTRANETICS SPECTRANETICS MODIFICATIONS TO THE
03/24/95 CVX-300 EXCIMER CORPORATION INNER LUMEN AND TIP
LASER SYSTEM COLORADO SPRINGS, CO OF THE METAL RIM
80907 CATHETER MODELS
PC1014M, 114-001,
PC1017M, 117-002,
PC1120M, AND 120-001
P910007/S2 ABBOTT AXSYM PSA ABBOTT LABORATORIES MODIFICATIONS TO THE
03/29/95 ABBOTT PSA EIA DEVICE
ABBOTT PARK, IL TO FACILITATE THE
60064-3500 USE OF THE ASSAY ON
THE ABBOTT AXSYM
ANALYZER
P910020/S9 RELAY/DASH/STRIDE INTERMEDICS, INC. USE OF WILSON
03/01/95 /DART PACING GREATBATCH BATTERIES
SYSTEMS ANGLETOWN, TX /MODIFICATION OF THE
77515 BATTERY
SPECIFICATIONS
P910056/S1 MODELS C24UB, CHIRON VISION APPROVAL OF THE
03/31/95 C29UB, C31UB, AND CORPORATION CHIROFLEX MODELS
C33UB IRVINE, CA C24UB, C29UB, C31UB
ULTRAVIOLET-ABSOR 92718-1903 ULTRAVIOLET-ABSORBING
BING SILICONE SILICONE POSTERIOR
POSTERIOR CHAMBER CHAMBER INTRAOCULAR
INTRAOCULAR LENSES
LENSES
P910058/S1 MODEL C10UB CHIRON VISION APPROVAL FOR THE
03/29/95 ULTRAVIOLET-ABSOR CHIROFLEX MODEL C10UB
BING SILICONE IRVINE, CA ULTRAVIOLET-ABSORBING
POSTERIOR CHAMBER 92718-1903 SILICONE POSTERIOR
INTRAOCULAR LENS CHAMBER INTRAOCULAR
LENS AND FOR
STAAR SURGICAL
COMPANY TO DISTRIBUTE
P910075/S2 COMPLETE BRAND ALLERGEN OPTICAL USE OF COMPLETE BRAND
03/23/95 LUBRICATING AND MULTI-PURPOSE
REWETTING DROPS IRVINE, CA SOLUTION AS
92713-0534 LUBRICATING AND
REWETTING DROPS, NEW
TRADE NAME COMPLETE
BRAND LUBRICATING AND
REWETTING DROPS
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